# K050843: Axxent Electronic Brachytherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Xoft, Inc.
- Decided: Dec 22, 2005 after 265 days
- Product code: JAD (System, Therapeutic, X-Ray)
- Device class: 2
- Regulation: 21 CFR 892.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K864210 (1986). 14 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992577: Photon Radiosurgery System (PRS), Photoelectron Corporation (1999) Summary page 1.
- K945383: High Dose Rate Afterloader, Varian Assoc., Inc. (1995) Summary page 1.
- K011690: Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray, Proxima Therapeutics, Inc. (2002) Summary page 1.
- K030558: Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray, Proxima Therapeutics, Inc. (2003) Summary page 1.
- K032067: Mammosite Radiation Therapy System (RTS) Tray, Mammosite  HDR Afterloader Accessories Tray, Proxima Therapeutics, Inc. (2004) Summary page 1.

## Most influential descendants
- K072683: Axxent Electronic Brachytherapy System (2008), 5 descendants of its own
- K122951: Xoft Axxent Electronic Brachytherapy System Model 110 (2013), 4 descendants of its own
- K153570: Axxent Electronic Brachytherapy System Model 110 XP 1200 (2016), 1 descendant of its own
- K132092: Esteya (2013), 1 descendant of its own
- K090914: Axxent Balloon Applicator, Model AB2034, AB2045, AB2056, AB2057E, AB2067E (2009), 1 descendant of its own

## Indications for use
The Xoft Axxent Electronic Brachytherapy System is intended to provide brachytherapy when the physician chooses to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer. The safety and effectiveness of the Axxent Electronic Brachytherapy System as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.

Source page: https://510kreport.com/device/K050843
Methodology: https://510kreport.com/methodology